AVE7688 in Patients With Mild to Moderate Blood Pressure

• Patients with mild-to-moderate, treated or untreated, essential hypertension, as defined by the JNC VII (Joint National Committee on the Prevention, Detection, Evaluation, and

Treatment of High Blood Pressure, Seventh report ) guidelines who meet the following BP eligibility criteria:

• mean SeSBP (Seated systolic blood pressure) ≥140 mm Hg and \<180 mm Hg and mean SeDBP (Seated diastolic blood pressure) ≥90 mm Hg and \<110 mm Hg at two consecutive qualifying visits in the placebo lead-in phase
• variability between the mean BP measurements on the 2 consecutive qualifying visits is less or equal 7 mm Hg for SeDBP.

Exclusion Criteria:

• Refusal or inability to give informed consent
• Patients who have previously been treated with AVE7688
• Patients who cannot stop their anti-hypertensive treatment
• Known history of secondary hypertension, including patients with endocrine disorders such as pheochromocytoma, active hyperthyroidism, or untreated hypothyroidism
• Severe hypertension
• Women of child bearing potential, who have a positive serum pregnancy test, or who do not agree to use an accepted method of contraception
• Women who are breast feeding
• Patients with non-cardiac progressive fatal disease
• Patients with immunological or hematological disorders
• Requirement for concomitant treatment that could bias the primary evaluation
• Unstable insulin-dependent diabetes mellitus
• History of stroke, intracranial hemorrhage or transitory ischemic attack within the previous year
• Likelihood of poor compliance both with treatment and study design
• Patient is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, or other staff member or relative there of directly involved in the conduct of the study
• Administration of any investigational drug within the preceding 30 days
• Abuse of drugs or alcoholic beverages within 1 year prior to the start of the study
• Patients taking herbal or dietary compounds that have the potential to influence blood pressure
• Contraindications to losartan-potassium as per local package insert
• History of hypersensitivity or angioedema with ACE inhibitors or NEP inhibitors, patients with hereditary or idiopathic angioedema, patients with allergic reaction in which urticaria or angioedema was the manifestation
• Impaired hepatic function
• Known unilateral or bilateral renal artery stenosis
• Serum potassium > 5.5 mmol/L
• Impaired renal function